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  • gaberuiz13 replied to the topic Customer Needs, Business Requirements, Test Plan in the forum Introduction to Design Controls 7 years, 5 months ago

    From the deliverables Dr. Simon requested for this class I noticed a lot of similarities between them and the deliverables we had to submit for the undergraduate capstone project. In capstone, we were required to submit a lengthy and extremely detailed requirements document and a test plan. My professor for capstone described that the requirements document should cover every customer need given to us by our customer and that it should be detailed enough that “you could give this to any average joe in the hall and he or she can make the device just based off the document”. The test plan was simply a document containing a test architecture to assure that our device is compliant with our customer needs and regulations from the FDA, ISO, etc. Our professor stressed that these types of documents are what is used in industry today and most likely will continue to be this way forever. He even provided evidence by showing us emails from former students who landed jobs because of their knowledge with handling these documents. Overall, these types of documents are prevalent and are very necessary in order to create a medical or any other type of device/ product.